EP2289574B1 - Medizinische Artikel und Verfahren zu deren Herstellung - Google Patents

Medizinische Artikel und Verfahren zu deren Herstellung Download PDF

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Publication number
EP2289574B1
EP2289574B1 EP10178073.2A EP10178073A EP2289574B1 EP 2289574 B1 EP2289574 B1 EP 2289574B1 EP 10178073 A EP10178073 A EP 10178073A EP 2289574 B1 EP2289574 B1 EP 2289574B1
Authority
EP
European Patent Office
Prior art keywords
wound guard
wound
antimicrobial agent
antimicrobial
projection
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP10178073.2A
Other languages
English (en)
French (fr)
Other versions
EP2289574A2 (de
EP2289574A3 (de
Inventor
Roger Bayston
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
University of Nottingham
Original Assignee
University of Nottingham
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by University of Nottingham filed Critical University of Nottingham
Publication of EP2289574A2 publication Critical patent/EP2289574A2/de
Publication of EP2289574A3 publication Critical patent/EP2289574A3/de
Application granted granted Critical
Publication of EP2289574B1 publication Critical patent/EP2289574B1/de
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/60—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like for external osteosynthesis, e.g. distractors, contractors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • A61L2300/406—Antibiotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/45—Mixtures of two or more drugs, e.g. synergistic mixtures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/025—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body through bones or teeth, e.g. through the skull
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0285—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port

Definitions

  • the two pieces of polymeric material are then butted together.
  • the two pieces may be joined together using polymer glue.
  • polymer glue When rifampin, clindamycin are used as antimicrobial agents in the silicone they have a tendency to migrate through the glue.
  • the two pieces may be held together under compression or the two pieces may be shaped so a dovetail or other mechanical joint holds the two pieces together. Diffusion will then occur with the antimicrobial agent in each piece migrating to the other respective piece. Diffusion can be accelerated by several techniques including heating, autoclaving, and applying ultrasound to the polymeric material.
  • the diffusion is accelerated so that each antimicrobial agent is distributed, possibly evenly distributed, throughout the device, or at least throughout a region of the device, before the device is used.
  • a first type of wound guard 30 comprising a disc 32 of silicone elastomer having a central bore 34.
  • the size of the bore 34 is chosen so that the transdermal device 36 may be placed through the bore 34 in a tight fit.
  • the wound guard 42 illustrated in Figures 13 and 14 has a projection 44 that has a cylindrical portion 44a distal from the disc portion and a concave portion 44b proximal to the disc portion 32.
  • the projection 44 may also be shaped so that there is no cylindrical portion 49a and the concave portion 44b, in this case, would extend from the disc portion to the end of the projection that has the bore 34 entrance.
  • the projection 44 instead of a concave portion 44b the projection 44 may have a convex portion 44c.
  • Figures 10 and 11 show the convex portion 44c extending from the disc portion 32 to the end of the projection 44 that has the bore 34 entrance but the projection 44 may also be shaped so that it has a distal cylindrical portion 44a.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Epidemiology (AREA)
  • Surgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)
  • External Artificial Organs (AREA)

Claims (13)

  1. Wundschutz umfassend einen Scheibenabschnitt mit einer Kontaktfläche zum Kontaktieren der Oberfläche der Haut eines Patienten und einer zweiten Oberfläche, die von der Kontaktfläche entfernt angeordnet ist, und einen Vorsprung, der von der zweiten Oberfläche wegragt, wobei der Vorsprung eine Bohrung aufweist, die durch den Vorsprung zu der ersten Oberfläche verläuft, wobei der Vorsprung angepasst ist, um eine transdermale Vorrichtung im Gebrauch in der Bohrung zu halten, wobei der Wundschutz mit einem ersten antimikrobiellen Mittel imprägniert ist und wobei das erste antimikrobielle Mittel Triclosan ist, wobei der Wundschutz mit einem zweiten antimikrobiellen Mittel imprägniert ist, so dass eine Mikrobe, die mutiert, um gegen eines der ersten und zweiten antimikrobiellen Mittel resistent zu sein, nicht gegen das andere der ersten und zweiten antimikrobiellen Mittel resistent sein wird, wobei das zweite antimikrobielle Mittel Rifamycin, Rifampin, Lincomycin oder Clindamycin ist.
  2. Wundschutz nach Anspruch 1, wobei der Wundschutz im Wesentlichen aus Polymermaterial besteht.
  3. Wundschutz nach Anspruch 2, wobei das Polymermaterial aus Silikonelastomer, Polyalkenen und Polyurethanlatex ausgewählt ist.
  4. Wundschutz nach Anspruch 3, wobei das Polymermaterial ein Silikonelastomer ist.
  5. Wundschutz nach Anspruch 1, wobei der Scheibenabschnitt aus Polymermaterial besteht.
  6. Wundschutz nach Anspruch 5, wobei der Vorsprung aus Polymermaterial besteht.
  7. Wundschutz nach einem der vorstehenden Ansprüche, wobei der Wundschutz mit einem dritten antimikrobiellen Mittel imprägniert ist, so dass die Wirkung der Mittel derart ist, dass eine Mikrobe, die zu einer Resistenz gegen zwei der antimikrobiellen Mittel mutiert, nicht gegen das andere antimikrobielle Mittel resistent sein wird.
  8. Wundschutz nach Anspruch 7, wobei, wenn das zweite antimikrobielle Mittel Lincomycin oder Clindamycin ist, dann ist das dritte antimikrobielle Mittel Rifamycin oder Rifampin, während, wenn das zweite antimikrobielle Mittel Rifamycin oder Rifampin ist, dann das dritte antimikrobielle Mittel Lincomycin oder Clindamycin ist.
  9. Wundschutz nach Anspruch 1, wobei eine Mikrobe, die an einem einzigen Mutationspunkt mutiert, um gegen eines der ersten und zweiten antimikrobiellen Mittel resistent zu sein, nicht mutieren darf, um gegen das andere der ersten und zweiten antimikrobiellen Mittel resistent zu sein.
  10. Wundschutz nach einem der vorstehenden Ansprüche, mit einer zweiten Oberfläche, die von der Kontaktfläche entfernt angeordnet ist und einen Vorsprung umfasst, der von einer zweiten Oberfläche wegragt, wobei die Bohrung durch den Vorsprung und den Scheibenabschnitt verläuft.
  11. Wundschutz nach einem vorstehenden Anspruch, wobei der Wundschutz transparent ist.
  12. Wundschutz nach einem vorstehenden Anspruch, wobei die transdermale Vorrichtung eines von einem zentralen Venenkatheter, einem kontinuierlichen ambulanten Peritonealkatheter, einem Harnkatheter, einer externen Ventrikeldrainage, einem externen Fixierstift oder Schraube zur Frakturstabilisierung und einem Katheter für eine Wunddrainage, Ommaya-Reservoir oder intraspinale Pumpe ist.
  13. Wundschutz nach einem der vorstehenden Ansprüche, wobei der Scheibenabschnitt und der Vorsprung integral ausgebildet sind.
EP10178073.2A 2004-09-23 2005-09-22 Medizinische Artikel und Verfahren zu deren Herstellung Not-in-force EP2289574B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB0421164.5A GB0421164D0 (en) 2004-09-23 2004-09-23 Medical devices and methods of making medical devices
EP05781960.9A EP1804845B1 (de) 2004-09-23 2005-09-22 Medizinprodukte und verfahren zur herstellung von medizinprodukten
PCT/GB2005/003667 WO2006032904A2 (en) 2004-09-23 2005-09-22 Medical devices and methods of making medical devices

Related Parent Applications (3)

Application Number Title Priority Date Filing Date
EP05781960.9 Division 2005-09-22
EP05781960.9A Division-Into EP1804845B1 (de) 2004-09-23 2005-09-22 Medizinprodukte und verfahren zur herstellung von medizinprodukten
EP05781960.9A Division EP1804845B1 (de) 2004-09-23 2005-09-22 Medizinprodukte und verfahren zur herstellung von medizinprodukten

Publications (3)

Publication Number Publication Date
EP2289574A2 EP2289574A2 (de) 2011-03-02
EP2289574A3 EP2289574A3 (de) 2014-07-02
EP2289574B1 true EP2289574B1 (de) 2019-07-17

Family

ID=33397131

Family Applications (3)

Application Number Title Priority Date Filing Date
EP10178073.2A Not-in-force EP2289574B1 (de) 2004-09-23 2005-09-22 Medizinische Artikel und Verfahren zu deren Herstellung
EP05781960.9A Active EP1804845B1 (de) 2004-09-23 2005-09-22 Medizinprodukte und verfahren zur herstellung von medizinprodukten
EP10178080.7A Active EP2272545B1 (de) 2004-09-23 2005-09-22 Antimikrobielle medizinische Vorrichtung und Verfahren zu deren Herstellung

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Application Number Title Priority Date Filing Date
EP05781960.9A Active EP1804845B1 (de) 2004-09-23 2005-09-22 Medizinprodukte und verfahren zur herstellung von medizinprodukten
EP10178080.7A Active EP2272545B1 (de) 2004-09-23 2005-09-22 Antimikrobielle medizinische Vorrichtung und Verfahren zu deren Herstellung

Country Status (6)

Country Link
US (2) US10500388B2 (de)
EP (3) EP2289574B1 (de)
JP (1) JP5393030B2 (de)
CA (1) CA2580894C (de)
GB (1) GB0421164D0 (de)
WO (1) WO2006032904A2 (de)

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JP2010088792A (ja) * 2008-10-10 2010-04-22 National Cardiovascular Center カフ部材及びカフ部材ユニット
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KR102258069B1 (ko) * 2012-07-10 2021-05-28 바이오메드 사이언시즈, 인크. 화상 사건에서 1차 반응자 사용을 위한 신규한 의료 조치
AU2016374654B2 (en) * 2015-12-24 2020-08-20 Jason Jit-Sun Tan Customisable stoma insert
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Also Published As

Publication number Publication date
JP2008513172A (ja) 2008-05-01
EP2272545A2 (de) 2011-01-12
EP2272545B1 (de) 2019-11-06
JP5393030B2 (ja) 2014-01-22
EP1804845A2 (de) 2007-07-11
EP1804845B1 (de) 2018-09-12
US20170354813A1 (en) 2017-12-14
EP2272545A3 (de) 2014-11-12
GB0421164D0 (en) 2004-10-27
US20070224243A1 (en) 2007-09-27
WO2006032904A3 (en) 2006-10-26
CA2580894A1 (en) 2006-03-30
US10500388B2 (en) 2019-12-10
EP2289574A2 (de) 2011-03-02
CA2580894C (en) 2013-06-25
WO2006032904A2 (en) 2006-03-30
EP2289574A3 (de) 2014-07-02

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